The Lynx Group

Quality Research and Patient Safety

April 2014, Vol 5, No 3

Avoidance of Fulminant Liver Failure from Hepatitis B Reactivation with Chemoimmunotherapy: A Value-Based Approach
Kevin B. Knopf, MD, MPH; and Samantha Siegel, MD

California Pacific Medical Center, San Francisco, California

Fulminant liver failure is an almost invariably fatal complication of hepatitis B reactivation seen in patients who are infected with Hepatitis B and receive Rituximab and other anti-CD20 immunotherapies. In addition, fulminant liver failure can occur in cancer patients with Hepatitis B who are receiving cytotoxic chemotherapy. Often patients receiving these regimens are treated with curative intent (e.g. diffuse large cell non-Hodgkin’s lymphoma, adjuvant chemotherapy for breast cancer) and thus avoidance of this complication is desirable. The only known treatment for fulminant liver failure in this setting is orthotropic liver transplant. We have developed a cost-effective approach to avoiding fulminant liver failure in a high risk population.

NCCN guidelines recommend screening for hepatitis B serologies in any patient who is to receive Rituximab therapy—which we extend to all therapies that are anti-CD20 including newer agents. Review of the literature regarding fulminant liver failure and cytotoxic chemotherapy revealed that the regimens most strongly associated with reactivation of HepB and fulminant liver failure were those that included doxorubicin and higher doses of cyclophosphamide. Therefore we have targeted Hepatitis B screening to patients receiving these two chemotherapy drugs.

To manage resources effectively we target patients felt to have a high probability of occult hepatitis B are screened—these include patients who have had a blood transfusion in a foreign country where screening of blood products for Hep B may not be 100%, those with a transfusion more than 20 years ago, and those patients where Hepatitis B can be passed vertically—including first and second generation Asian American immigrants.

Patients deemed at high risk are checked for Hepatitis B surface Antigen (HepBSag) and Hepatitis B Core (HepBCAb) antibodies only. No routine imaging is performed. Patients previously known to be HepBSag positive and patients who are discovered to be HepBSag positive who are to receive high-risk chemo/immunotherapy are then started on entecavir (Beraclude) 0.5 mg a day two weeks before starting therapy and this is continued for 6 months after completion of therapy. Patients who are HepBAg– and HepBCab+ are monitored with HBV DNA levels monthly during therapy with initiation of entecavir if HBV DNA becomes detectable.

By selectively screening enriched populations for occult HepB infection, treating appropriate patients with entecavir, and minimizing laboratory testing and imaging we have created a value-driven cost-effective approach to minimizing fulminant hepatic failure in patients receiving chemo/immunotherapy. Cost estimates based on San Francisco pricing will be presented with the poster.


Baseline Characteristics and Description of Authorizations for Erythropoiesis Stimulating Agents (ESAs): Step One of a Quality Improvement Program
Edward Li, PharmD, BCOP; Cecilia Tran, PharmD, BCOP; Barry Peterson, PharmD, BCOP, BCPS; Michael Sturgill; Stanley Forston Jr., MD, MPH

Background: Evaluating the use of ESAs in the treatment of chemotherapy-induced anemia (CIA) is important due to concerns related to the impact on tumor progression, appropriate prescribing and the cost of therapy. New Century Health (NCH) evaluates requests for ESAs based on diagnosis, laboratory values, chemotherapy and intent of treatment. The purpose of this project is to serve as the baseline data for a quality improvement initiative with the goal of improving adherence to best practices, optimizing outcomes, reducing cost, and increasing efficiency of authorization processing.
Methods: We evaluated authorizations in 2013 for only CIA in patients with the following tumor types: breast, lung, colon, prostate, and diffuse large B-cell lymphoma (DLBCL). ESA authorizations were analyzed for approval status of the request, and if applicable, the reasons for request withdrawal. Clinicodemographic characteristics of the cohort, including concurrent chemotherapy, are examined using descriptive statistics.

Results: There were 266 patients and 404 ESA authorizations in 2013 for patients (average age 70 years, 59% female, 41% male) with lung cancer (54%), breast cancer (21%), DLBCL (9%), prostate cancer (8%), and colon cancer (8%). The majority of patients had one authorization (65%); few had 4+ (4%). ECOG performance status was 0 or 1 in 66% of patients.

Authorizations were approved in 67% of the cases and were withdrawn or discontinued in 25% of cases. For 78% of authorizations, chemotherapy was ordered within 90 days preceding the ESA request.

Conclusions: The use of ESAs in patients with lung cancer is an area for further examination, as is the concurrent use of chemotherapy with ESA authorizations. Future implications are to further examine the effects of this management program on clinical outcomes, cost, and efficiency of processing authorizations.


Palonosetron for Chemotherapy-Induced Nausea and Vomiting: Description and Report of a Quality Management Program
Edward Li, PharmD, BCOP; Cecilia Tran, PharmD, BCOP; Barry Peterson, PharmD, BCOP, BCPS; Michael Sturgill; Stanley Forston Jr., MD, MPH

Background: There is currently no consensus regarding the best intervention for low emetogenic chemotherapies. Palonosetron is preferred by guidelines in high/moderate emetic chemotherapy but other treatment options may be more cost-effective in low-emetogenic regimens. This study describes a cohort of denied chemotherapy treatment authorization requests containing palonosetron for demographics, authorization request patterns, and cost.

Methods: This is a retrospective analysis of denied authorization requests containing palonosetron reviewed by New Century Health’s oncology quality management program from 1/2013 to 10/2013. Descriptive statistics identify: cohort demographics, reasons for withdrawal, and follow-up to authorization withdrawals. Lastly, cost impact was calculated based on the difference between the approved authorization request and the original, withdrawn request.

Results: We identified 378 cases; the cohort median age was 68 years with 42% men and 58% women. The most common tumor types were lung (24%), breast (21%), hematologic (11%), and colon/rectal/anal (10%). Reasons for denial include: no compendia support (81%), availability of therapeutic alternative (42%), clinical criteria not met (15%), and dosing/frequency errors (10%). The program prompted chemotherapy regimen changes in 156 cases and supportive care treatment changes in 222 cases; palonosetron was removed in 31% and 51% of the cases respectively. The total net cost savings based on all the changes within the cohort was $1,087,073. Evidence-based changes in therapy that resulted in enhanced care quality and increased cost totaled $757,473.

Conclusions: Palonosetron, while effective, may not be the most cost-effective option for low-emetic regimens considering other lower-cost 5HT3 antagonists are available. We were able to drive utilization toward the lower-cost antiemetic medications and influence changes in evidence-based chemotherapy prescribing choices.

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